Events

Futuro Quick Strap Ankle Support 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 3M Australia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2018-RN-00116-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-02-19
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00116-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer is aware that there is natural rubber latex (1%) in the futuro quick strap ankle support. currently packaging of this product does not have an explicit caution statement in relation to latex.The existing caution statement available on this product is "caution: some individuals may be sensitive to neoprene or neoprene blend rubber. if a rash develops, discontinue use and consult a physician".Individuals that are sensitive to latex may develop an allergic reaction.No alleged medical complaints regarding this product have been received in australia during its period of distribution.This recall does not affect any other 3m products.
  • 조치
    3M is advising pharmacies to quarantine affected stock and return it to the distributor. 3M will arrange collection of affected devices from distributors.

Device

Futuro Quick Strap Ankle Support
  • 모델명 / 제조번호(시리얼번호)
    Futuro Quick Strap Ankle Support Product Code: 47736EN3M Code: 70005091510All batch/lot numbers are affectedARTG Number: 214679
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd